Comparison Between Methotrexate and Mycophenolate Mofetil Monotherapy for the Control of Noninfectious Ocular Inflammatory Diseases

SITE Cohort Research Group

Research output: Contribution to journalArticle

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Abstract

Purpose: To compare mycophenolate mofetil (MMF) to methotrexate (MTX) as corticosteroid-sparing therapy for ocular inflammatory diseases. Design: Retrospective analysis of cohort study data. Methods: Participants were identified from the Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Demographic and clinical characteristics were obtained via medical record review. The study included 352 patients who were taking single-agent immunosuppression with MTX or MMF at 4 tertiary uveitis clinics. Marginal structural models (MSM)-derived statistical weighting created a virtual population with covariates and censoring patterns balanced across alternative treatments. With this methodological approach, the results estimate what would have happened had none of the patients stopped their treatment. Survival analysis with stabilized MSM-derived weights simulated a clinical trial comparing MMF vs MTX for noninfectious inflammatory eye disorders. The primary outcome was complete control of inflammation on prednisone ≤10 mg/day, sustained for ≥30 days. Results: The time to success was shorter (more favorable) for MMF than MTX (hazard ratio = 0.68, 95% confidence interval: 0.46-0.99). Adjusting for covariates, the proportion achieving success was higher at every point in time for MMF than MTX from 2 to 8 months, then converges at 9 months. The onset of corticosteroid-sparing success took more than 3 months for most patients in both groups. Outcomes of treatment (MMF vs MTX) were similar across all anatomic sites of inflammation. The incidence of stopping therapy for toxicity was similar in both groups. Conclusions: Our results suggest that, on average, MMF may be faster than MTX in achieving corticosteroid-sparing success in ocular inflammatory diseases.

Original languageEnglish (US)
Pages (from-to)68-75
Number of pages8
JournalAmerican journal of ophthalmology
Volume208
DOIs
StatePublished - Dec 1 2019

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Mycophenolic Acid
Eye Diseases
Methotrexate
Adrenal Cortex Hormones
Structural Models
Cohort Studies
Inflammation
Therapeutics
Uveitis
Immunosuppressive Agents
Survival Analysis
Prednisone
Immunosuppression
Medical Records
Demography
Clinical Trials
Confidence Intervals
Weights and Measures
Incidence

ASJC Scopus subject areas

  • Ophthalmology

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Comparison Between Methotrexate and Mycophenolate Mofetil Monotherapy for the Control of Noninfectious Ocular Inflammatory Diseases. / SITE Cohort Research Group.

In: American journal of ophthalmology, Vol. 208, 01.12.2019, p. 68-75.

Research output: Contribution to journalArticle

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abstract = "Purpose: To compare mycophenolate mofetil (MMF) to methotrexate (MTX) as corticosteroid-sparing therapy for ocular inflammatory diseases. Design: Retrospective analysis of cohort study data. Methods: Participants were identified from the Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Demographic and clinical characteristics were obtained via medical record review. The study included 352 patients who were taking single-agent immunosuppression with MTX or MMF at 4 tertiary uveitis clinics. Marginal structural models (MSM)-derived statistical weighting created a virtual population with covariates and censoring patterns balanced across alternative treatments. With this methodological approach, the results estimate what would have happened had none of the patients stopped their treatment. Survival analysis with stabilized MSM-derived weights simulated a clinical trial comparing MMF vs MTX for noninfectious inflammatory eye disorders. The primary outcome was complete control of inflammation on prednisone ≤10 mg/day, sustained for ≥30 days. Results: The time to success was shorter (more favorable) for MMF than MTX (hazard ratio = 0.68, 95{\%} confidence interval: 0.46-0.99). Adjusting for covariates, the proportion achieving success was higher at every point in time for MMF than MTX from 2 to 8 months, then converges at 9 months. The onset of corticosteroid-sparing success took more than 3 months for most patients in both groups. Outcomes of treatment (MMF vs MTX) were similar across all anatomic sites of inflammation. The incidence of stopping therapy for toxicity was similar in both groups. Conclusions: Our results suggest that, on average, MMF may be faster than MTX in achieving corticosteroid-sparing success in ocular inflammatory diseases.",
author = "{SITE Cohort Research Group} and Gangaputra, {Sapna S.} and Newcomb, {Craig W.} and Joffe, {Marshall M.} and Kurt Dreger and Hosne Begum and Pichaporn Artornsombudh and Pujari, {Siddharth S.} and Ebenezer Daniel and Sen, {H. Nida} and Eric Suhler and Thorne, {Jennifer E.} and Bhatt, {Nirali P.} and Foster, {C. Stephen} and Jabs, {Douglas A.} and Nussenblatt, {Robert B.} and Rosenbaum, {James (Jim)} and Levy-Clarke, {Grace A.} and Kempen, {John H.}",
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AU - SITE Cohort Research Group

AU - Gangaputra, Sapna S.

AU - Newcomb, Craig W.

AU - Joffe, Marshall M.

AU - Dreger, Kurt

AU - Begum, Hosne

AU - Artornsombudh, Pichaporn

AU - Pujari, Siddharth S.

AU - Daniel, Ebenezer

AU - Sen, H. Nida

AU - Suhler, Eric

AU - Thorne, Jennifer E.

AU - Bhatt, Nirali P.

AU - Foster, C. Stephen

AU - Jabs, Douglas A.

AU - Nussenblatt, Robert B.

AU - Rosenbaum, James (Jim)

AU - Levy-Clarke, Grace A.

AU - Kempen, John H.

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N2 - Purpose: To compare mycophenolate mofetil (MMF) to methotrexate (MTX) as corticosteroid-sparing therapy for ocular inflammatory diseases. Design: Retrospective analysis of cohort study data. Methods: Participants were identified from the Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Demographic and clinical characteristics were obtained via medical record review. The study included 352 patients who were taking single-agent immunosuppression with MTX or MMF at 4 tertiary uveitis clinics. Marginal structural models (MSM)-derived statistical weighting created a virtual population with covariates and censoring patterns balanced across alternative treatments. With this methodological approach, the results estimate what would have happened had none of the patients stopped their treatment. Survival analysis with stabilized MSM-derived weights simulated a clinical trial comparing MMF vs MTX for noninfectious inflammatory eye disorders. The primary outcome was complete control of inflammation on prednisone ≤10 mg/day, sustained for ≥30 days. Results: The time to success was shorter (more favorable) for MMF than MTX (hazard ratio = 0.68, 95% confidence interval: 0.46-0.99). Adjusting for covariates, the proportion achieving success was higher at every point in time for MMF than MTX from 2 to 8 months, then converges at 9 months. The onset of corticosteroid-sparing success took more than 3 months for most patients in both groups. Outcomes of treatment (MMF vs MTX) were similar across all anatomic sites of inflammation. The incidence of stopping therapy for toxicity was similar in both groups. Conclusions: Our results suggest that, on average, MMF may be faster than MTX in achieving corticosteroid-sparing success in ocular inflammatory diseases.

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